untitled
Staff news Help Us To Save The Trees!
No Third Copy of New Chemical Notifications!
Review and Treaties Team
New starters at NICNAS
Natalie Hitoun
NICNAS only requires two (2) copies of a new chemical notification dossier.
Natalie has qualifications in the sociology of scientific knowledge,
and wide-ranging experience that includes many years teaching Science
ISSUE THIRTEEN June 2005. The NICNAS newsletter.
When you send a third copy, it ends up in the bin (shredded as confidential
and a year with the Military Compensation and Rehabilitation Scheme
waste, naturally).
(Department of Veterans Affairs).
Please, help us lessen our impact on the trees and forests of the world by
Business Management and Communications
only sending the two copies we require.
Nora Estanislao
New Reporting Obligations: Annual Reporting
Nora is working as Finance and Administration Officer. She has worked
What's new @ www.nicnas.gov.au
Type of assessment Number of copies required
for the NSW Government's TransGrid and Pacific Power, as well as with
Standard (STD) 2
UNICEF.
Requirements for Chemical Introducers Chemical Gazette ?December 2004
Limited (LTD) 2
Richard Rose http://www.nicnas.gov.au/publications/gazette/
New starters at NICNAS front row, from left to right: David Salter, Craig Tonks, Nora Estanislao,
Richard is involved in administrative duties and the processing Polymer of low concern (PLC) 2
Rhonda Tang, Amith Senanayake; back row, from left to right: Richard Rose, Jonathan Krygier, chemgazettedec2004.asp
Stuart Wilson, Naomi Degabriele, Ed Cram, Jennifer Turner, Monique Wilson, Natalie Hitoun, and delivering of all mail. Extension of an original STD, LTD 1 only Chemical Gazette ?January 2005
Amendments to the Industrial Chemicals (Notification and Assessment) The due date for both annual reports is 28 September 2005.
Cameron Dalgleish, John Sawkins.
or PLC assessment
John Sawkins http://www.nicnas.gov.au/publications/gazette/
Act 1989 (the Act) in 2004 introduced a range of exemptions that allows
NICNAS is currently working closely with our database and web design chemgazettejan2005.asp
John is Communications Officer, managing NICNAS's various publications Commercial Evaluation (CEC) 1 only introducers of industrial chemicals to import and/or manufacture a new
In the last few months, NICNAS has welcomed a number
teams to provide a method of reporting which enables participants
and other forms of communication. He formerly worked for NSW industrial chemical without notification. Chemical Gazette ?February 2005
Low Volume Chemicals (LVC) 1 only
of new staff.
to lodge their reports online via the NICNAS website.
Government departments and in public affairs and communication Articles include: Call for information on chemicals included
To ensure the maintenance of health, safety, and environmental protection
for overseas development agencies. in the Rotterdam Convention, Publication of new Compliance
Notification and Assessment ?New Chemicals Team NICNAS has established a Technical Working Group to develop guidance
from the use of chemicals introduced under these exemptions, there are Guidance Material on the website.
Naomi Degabriele
Staff Achievements and procedures. The Group will comprise representatives from industry,
now requirements for introducers to report these new chemicals and their
2005 Year in Industry students http://www.nicnas.gov.au/publications/gazette/
Naomi's studies focussed on Gene Therapy and Biotechnology. community and government, and hold its first meeting on 1 July 2005.
quantity every 12 months, for the previous registration year (1 September ? chemgazettefeb2005.asp
Rhonda Tang
She has worked in the private sector in both Sydney and the UK, 31 August). Chemical Gazette ?March 2005
Rhonda is a Bachelor of Science student majoring in Chemistry and Material Since 1999 the Department of Immigration and Multicultural and Indigenous A discussion paper outlining the proposed model for annual reporting
and also worked as a corporate lawyer and piano teacher.
Articles include: Priority Existing Chemical (PEC) Program ?br>
Science at the University of Sydney, who is initially working in Compliance Affairs has run Harmony Day. of chemicals introduced under an exemption, will be available for public
In addition to the reporting requirements for chemicals introduced under
Ed Cram call for information, Octobromobiphenyl and Decabromobiphenyl
and will rotate to BMC, then New and Existing Chemicals later. comment by late July 2005 at http://www.nicnas.gov.au/publications/pdf/
exemptions, other annual reporting requirements are also now in effect.
Ed's expertise is in the fields of Protein Chemistry and Structural as PECs.
On Harmony Day, community groups, businesses, schools and individuals
Jonathan Krygier annualreportingmodel.pdf.
Introducers issued:
Biochemistry; he concentrated on the use of NMR for structure http://www.nicnas.gov.au/publications/gazette/
throughout Australia stage events of various kinds to promote harmony
Jonathan has finished his second year of Chemistry at the University 1. a commercial evaluation permit, or
determination in his studies. chemgazettemar2005.asp
Regular updates on the development of the annual reporting system
in their area, share experiences and express support for Australia's success
of Sydney and will be rotating through the various NICNAS teams, getting 2. a low volume permit, or
Craig Tonks Chemical Gazette ?April 2005
will be provided on our website over coming months.
as a multicultural society.
a feel for the different areas of work, commencing with Existing Chemicals. 3. a self assessed assessment certificate
With a clinical chemistry background, Craig spent 11 years at WorkCover Articles include: NICNAS Cost Recovery Impact Statement.
are also required to report the name and volume of the chemical for which
If you have comments or enquiries about annual reporting requirements
NSW and was most recently a crime scene officer with NSW Police http://www.nicnas.gov.au/publications/gazette/
The day coincides with the United Nations International Day for the
During the same period we farewelled long-serving staff including the permit or certificate was issued, as well as any adverse effects on
chemgazetteapr2005.asp
please contact:
Forensic Services. Elimination of Racial Discrimination, and gives Australians the opportunity
Byron Chu, Louise Seery and Dusanka Sabic. occupational health and safety, public health or the environment of which
Lewis Norman, Team Leader, Data Analysis & Information
to: Chemical Gazette ?May 2005
Jennifer Turner the introducer has become aware during the previous registration year.
Phone: 02 8577 8854
?promote our community's success as a multicultural society Articles include: Summary of Information on Polybrominated
Jennifer has come to NICNAS from the University of Sydney School
Email: lewis.norman@nicnas.gov.au Flame Retardants, Low Regulatory Concern Chemicals (LRCC) ?br>
?re-commit ourselves to respect, goodwill and understanding
of Chemistry where she was a postdoctoral fellow. Her most recent research
Staff members of the month Controlled Use Permits ?Chemicals for export only,
between all Australians of all backgrounds, and
involved assessing antifreeze proteins (from Antarctic fish) as potential
Code of Practice ?Update and Guidance note for Asbestos.
?say `no' to racism.
cryoprotectants for the longterm storage of spermatozoa and embryos.
E-Notification of New Chemicals ?a rewarding activity http://www.nicnas.gov.au/publications/gazette/
January 2005 ?Cheryl Arndell
chemgazettemay2005.asp
At NICNAS in Sydney, the Harmony Day 2005 was observed with a sausage
Compliance Team Cheryl carried an extra load for a period of time when she picked up Finance
sizzle lunch, followed by a quick trivia quiz. Chemical Gazette ?June 2005
work in addition to the general administrative and Tier 1 Registration work.
Amith Senanayake Here at NICNAS we try our best to keep up with technology, and we're Non-PLC Self Assessment
Articles include: Declaration of PBFRs (Fire Retardants).
Amith's qualifications and wide experience are in Agriculture big fans of all the advantages that modern word processing offers when We look forward to receiving our first non-PLC self-assessment. Previously
As well, Director Margaret Hartley announced two special awards: http://www.nicnas.gov.au/publications/gazette/
February 2005 ?Naomi Degabriele
and Environmental and Natural Resource management, and he has worked compiling our new chemical assessments. For this reason we are you could only self-assess a PLC, but we have recently extended this
chemgazettejune2005.asp
Naomi undertook extensive drafting of the Standard Operating Procedures
for NSW Agriculture and the Department of Agriculture, Fisheries encouraging new chemical notifiers to submit electronic versions of their to cover self-assessment for non-hazardous chemicals, with a separate
* SPECI
AL
(SOP) for New Chemicals activities. The SOP is a complex document Cosmetics/Therapeutic goods interface review ?br>
and Forestry. notifications ?whether self-assessments or draft (template) assessment sub-category for non-hazardous polymers (that don't qualify as PLCs) with
AC
H IE
intended as a ready reckoner for all assessors. It includes useful information draft report for comment
reports. a Number Average Molecular Weight (NAMW) >1000.
Stuart Wilson
NER http://www.nicnas.gov.au/obligations/reform/default.asp
for activities that may not be undertaken on a regular basis.
Stuart worked as a research assistant at University of NSW,
NT
Final report on hazard classification of common skin sensitisers
AW
Furthermore, because e-notification makes our life easier when we are Once again there are substantial savings to be made on the application fees:
and his principal area of scientific interest is Biology.
W
W
AR
?br>
IP
March 2005 ?Deanna Kettle and Julie Brown D*
SH http://www.nicnas.gov.au/publications/CAR/PEC/default.asp -
assessing notifications, you can qualify for reduced fees, reduced time ?$8,035 for non-hazardous chemicals, and
W
Deanna and Julie made an `above and beyond' commitment to the other
LLO
frames, or sometimes even both, in return. ?$6,730 for non-hazardous polymers NAMW>1000
Data Analysis and Information Team
Deborah Willcocks
WIN
und
relocation of the Office of Chemical Safety in Canberra from the Edmund
(compared to $11,216 or $13,391 for a Limited or Standard notification, Information concerning New Chemicals Exemptions
Cameron Dalgleish
O
re
Barton Building to Woden. This included ensuring that all records were
F
Nick Miller
The Handbook for Notifiers has been updated to reflect
PLC Self Assessment respectively).
RD
Cameron comes to NICNAS from the Australian Trade Commission safely relocated, all packing was completed on schedule, and that several WA
changes following the introduction of the Industrial Chemicals
If you are notifying a Polymer of Low Concern (PLC), preparing
W
AL AW
where he was working as a business analyst. He studied Science communication activities (such as the mailout of postcards advising
(Notification and Assessment) Amendment (Low Regulatory
a self-assessment will save you 40% off the application fee, and 2 months As for PLCs, you have to complete the Self-Assessment Report, which is
and Asian Studies at the Australian National University. of the relocation) ran smoothly.
Concern Chemicals) Act 2004 (LRCC Amendment Act).
off the processing time. There are two main provisos. As an Australian found on the website at www.nicnas.gov.au/forms/
The 2004 Duleep Jayemanne Memorial Award for Fellowship,
David Salter Changes are to be found in Section 2 of the Handbook.
notifier you must: (Form 1-Self-Assessment non PLC, under the heading `Other New Chemicals
presented to Nick Miller (Team leader, Business Strategy
David has worked for the past twenty years as a scientific officer and http://www.nicnas.gov.au/publications/handbook/
?hold all supporting data for the notification, including all toxicological Notification Forms') and send it to us in electronic format. As the Australian
and Communication) for his loyalty and dedication to the organisation,
analytical chemist in chemical testing facilities, mainly with the Department
(`tox') studies, test reports for physico-chemical properties, notifier, you must hold all supporting data (similarly to the requirement Template for preparation of Commercial Evaluation (CEC)
camaraderie and fellowship amongst colleagues, a genuine love of life
of Mineral Resources.
spectral data confirming chemical identity, etc, and for PLC self assessments). submission. With guidance material
and a positive attitude.
http://www.nicnas.gov.au/forms/cectemplate.asp
?send us a completed Self-Assessment Report in electronic form.
Limited and Standard Template Reports Template for preparation of Low Volume Chemical (LVC)
The 2004 Special Achievement Award, presented to
If you can do both of these, the fee is $2,266 compared to $3,777 For the two major notification categories ?limited (LTD) and standard (STD) submission. With guidance material.
Deborah Willcocks (Team leader, Rapid Risk Assessment) in recognition
for a regular PLC assessment. notifications ?you can get up to 15% off the application fee by preparing a http://www.nicnas.gov.au/forms/lvctemplate.asp
of her outstanding efforts in leading the successful establishment
draft assessment report using our report template.
and implementation of the NICNAS Registration Project. The project has The NICNAS website
The PLC Self-Assessment Report template is on our website
been delivered with innovation and commitment within a cross function NICNAS and partner agencies in the TGA Group of Regulators
at www.nicnas.gov.au/forms/. It's called Form 1-PLC Self Assessment Because this means that you are essentially doing some of our assessing
team structure and represents a major reform within industrial chemical use the internationally acclaimed CSIRO P@noptic search
and you will find it under `Assessment Certificate'. You can download work for us, as a cost recovery agency we will reward you by giving back up
engine. With a user-friendly front-end, intuitive administrative
regulation in Australia.
the Word version to complete and send to us electronically. to 15% of the fee, depending on the quality of the report you draft interface and powerful reporting features, it enables clients
Continued on page 2 > to easily search our website for relevant information.
Because the NICNAS website receives thousands of visits each
?Commonwealth of Australia 2005
NICNAS matters is published by the National Industrial Chemicals
What's inside... week, managing and improving it is a constant work in progress.
Notification and Assessment Scheme This work is copyright. Apart from educational or training purposes and any use as permitted
Please look out for major changes in the `look and feel' of the
334-336 Illawarra Rd, Marrickville NSW 2204 under the Copyright Act 1968, no part may be reproduced by any process without prior ?Australian High Volume Industrial Chemicals List website, as well as ongoing improvements to navigation and
written permission from the Commonwealth. Requests and inquiries concerning reproduction
ISSN 1444-1209
operation, over the next quarter.
?Polybrominated Flame Retardants
Editorial Team: John Sawkins, Nick Miller and rights should be addressed to the Commonwealth Copyright Administration,
Design: Ident Attorney General's Department, Robert Garran Offices, National Circuit, Canberra ACT 2600 ?Sodium Cyanide
Contact: NICNAS matters, GPO Box 58, Sydney NSW 2001 or posted at http://www.ag.gov.au/cca
?Changes to NICNAS Fees and Charges
Inquiries: Phone: (02) 8577 8800 Fax: (02) 8577 8888
?Cosmetics
Freecall: 1800 638 528 Email: info@nicnas.gov.au NICNAS matters is printed on Nordic Swan environmental label accredited paper
Assessing chemicals for your protection
< Continued from page one
Cosmetics Update Cosmetics ?Did you know?
Progress with the IPCS Harmonisation Project (i.e. how helpful it has actually been to us). The saving will take the form Coming soon
of a rebate at the end of the assessment, when the certificate is issued. A template for Limited and Standard draft reports on the NICNAS website.
Workshops on notification procedures. Please watch this space!
NICNAS continues its involvement in the International Programme In Australia, the distinction between a cosmetic product and a therapeutic NICNAS regularly receives questions about its assessment of chemical
At this stage, NICNAS will consult with the full range of its stakeholders,
As you can imagine, when it comes to using your draft report to compile our
on Chemical Safety (IPCS) Harmonization Project ?in full: `Project on the good is based predominately on label claims. Products that make ingredients in cosmetics because such ingredients come under its regulatory
including the cosmetics industry and the community, to seek feedback
assessment, it is quite important for us to have it in electronic format, so we
For more information please contact:
Harmonization of Approaches to the Assessment of Risk from Exposure therapeutic claims are deemed to be therapeutic goods and are regulated control.
on principles relevant to cosmetics and discuss implementation issues.
ask you to always send an electronic version. Please email your request for
Hana Hamdan, Team Leader, Notification and Assessment
to Chemicals'. In October 2004 Director Dr Margaret Hartley chaired by the Therapeutic Goods Administration (TGA), while products that
the template to us at info@nicnas.gov.au.
Phone: (02) 8577 8855
a meeting of the Project's Steering Committee and Core Group in Cincinnati, do not make therapeutic claims are regulated as cosmetics by NICNAS. The Australian Government regulates cosmetics
Risk of spread of Transmissible Spongiform Encephalopathies
CEC and LVC Permits Template Reports Email: hana.hamdan@nicnas.gov.au
Ohio, USA at which the group agreed on a new Strategic Plan and key Australia's world standard regulatory system for cosmetics means that:
(TSEs) through cosmetics
There are now also electronic report templates available on the NICNAS
activities for 2005-08. In addition to the notification and assessment of cosmetics ingredients, ?only industrial chemicals listed on the Australian Inventory of Chemical
Transmissible Spongiform Encephalopathies (TSEs) are degenerative
1 At the time of writing, Form 1-PLC Self Assessment still quoted the old fee of $3,777, with mention
forms web page (http://www.nicnas.gov.au/forms/) for both Commercial Substances (AICS) or notified to NICNAS can be used as ingredients
NICNAS is engaged in several activities relating to the regulation diseases affecting the brain of humans and certain animal species. Variant
of a 15% discount. Please disregard this. The new fee is $2,266 ?a much greater discount!
Evaluation (CEC) and Low Volume (LVC) permits. They're under `Permit', in cosmetics
Foremost amongst the Cincinnati group's tasks was to discuss the findings of cosmetics. The main activities are summarised below. Creutzfeldt-Jakob Disease (vCJD), a human TSE, is believed to be caused by
This update prepared by Naomi Degabriele.
the second heading, next to yellow *NEW* flags
of a 2004 stocktake which had been designed to evaluate the outcomes ?all new cosmetic ingredients (i.e. those not listed on the AICS or whose
the agent responsible for Bovine Spongiform Encephalopathy (BSE) in cattle,
(see http://www.nicnas.gov.au/forms/cectemplate.asp and introduction is subject to a condition of use) must be notified
of the project since its inception in 1993-94, to collect feedback on the Reforms at the cosmetic/therapeutic interface and it is accepted that BSE can be transmitted from cattle to humans
http://www.nicnas.gov.au/forms/lvctemplate.asp respectively).
use/usefulness of the products of the project, to identify gaps or issues Australia has one of the most stringent regulatory systems in the world and assessed prior to their use in consumer products
through contaminated food. There have been no reported cases of vCJD
and gather proposals for future work. for cosmetics. Notwithstanding, the NICNAS Low Regulatory Concern ?concerns about existing ingredients (i.e. those chemicals listed on AICS
in Australia and there are no reports of transmission of BSE through the use
You can download the templates as Word documents to fill in electronically.
Chemicals (LRCC) reform activity identified possible areas for reform with uses within stipulated conditions) are reviewed to ensure
of cosmetics containing bovine derived materials. However, NICNAS
As permits are already a low-cost, swift-throughput category, no further
Another task was to confirm new wording for the Project's goal statement, for which consumer safety can still be maintained while reducing some the chemicals remain safe for use.
is of the view that in the interest of public health and safety, exposure
rebates or time savings are available. However, you will find that using
which now reads: `To improve chemical risk assessment generally, through elements of regulatory requirements. The LRCC Task Force recommended to the BSE agent through cosmetics should be minimised.
these templates is the best way of working out exactly what information we
the pursuit of common principles and approaches and hence, strengthen that the following products at the cosmetic-therapeutic interface Special labelling requirements
need for our assessment, and how it should be organised, and this will help
national and international management practices which deliver better be considered for reform: antiperspirants, mass-market anti-dandruff Labelling of cosmetic products is governed by the Trade Practices Act 1974.
NICNAS will work cooperatively with the cosmetics industry and the
you to prepare a complete submission that we can start assessing as soon
protection of human health and the environment within the framework shampoos, moisturisers with SPF, antibacterial skin washes and anti-acne Under this act, the mandatory standard for labelling dictates that all
community to formulate proposals aimed at minimising the potential risk
as it arrives, rather than having to request further information and/or clarify
of sustainability.' cleansers (recommendation 5.4 of the LRCC Report). ingredients in cosmetics and toiletries must be listed (in descending order
of TSE through cosmetics and toiletries. A public discussion paper
the data, which extends the time before the permit can be issued.
of weight or volume). This ensures users are fully informed of the chemicals
on proposed regulatory action is planned for 2005-06.
Submitting an E-Notification
Stocktake responses contributed to the Cincinnati discussions and these, In mid-2006, Australia's TGA and the New Zealand Medicines and Medical in the product, so they can avoid chemicals they are sensitive to or
in turn, impacted decision-making about the future shape of the Project Devices Safety Authority (Medsafe) will be replaced by a single agency, concerned about.
The National Health and Medical Research Council (NHMRC) Special Expert
and its new Strategic Plan. The steering committee agreed to continue the Trans-Tasman Regulatory Agency (TTRA), accountable to both Committee on Transmissible Spongiform Encephalopathies (SECTSE)
activities such as: the Australian and New Zealand governments. The new agency will regulate Naturally-occurring, natural and organic chemicals
provides the Australian Government with independent specialist scientific
We are keen to encourage clients to submit electronic files for self-assessments and draft (template) reports.
?Cancer ?completion of the guidance extending the IPCS Cancer therapeutic products in both countries, including medical devices Naturally-occurring chemical is defined under the Industrial Chemicals
advice on all matters necessary to prevent and limit the spread of TSEs
Memorandum Of Agreement Framework to include consideration and prescription, over-the-counter and complementary medicines. Cosmetic (Notification and Assessment) Act 1989 (the Act) as:
in Australia. NICNAS will seek the views of this expert committee on any
However, new chemicals assessment is still largely a paper-based process.
of the human relevance of animal tumours chemicals will continue to be regulated separately by NICNAS in Australia, proposed activity in relation to TSEs and cosmetics.
For security reasons we need to see original signatures on all forms, and we need hard copies of all supporting data.
?Exposure assessment ?development of harmonised guidance and the Environmental Risk Management Agency (ERMA) in New Zealand an unprocessed chemical occurring in a natural environment,
on characterising and communicating uncertainty in exposure (as applicable). or a substance that is extracted by manual, mechanical or gravitational
Review of chemicals used in hair dyes
We are working towards introducing an email submission category and will keep you posted as things develop.
assessment means, dissolution in water, flotation, or a process of heating
The current NICNAS review of chemicals used in hair dyes is complementary
Checklist
?Terminology ?maintenance, translation into other languages NICNAS and the TGA jointly commissioned a review of product at the for the sole purpose of removing uncombined water, without
to international regulatory activity. The overall aim of this review is to
?Please send notifications in a single package (rather than in instalments).
and promotion of two recently finalised publications: `Descriptions cosmetic/therapeutic interface by an independent consultant, Mr. David a chemical change in the substance, and chemicals that meet
ensure that chemicals used in hair dyes in this country meet contemporary
of selected key generic terms used in chemical/hazard risk assessment' Newgreen. As part of the review, extensive consultation was undertaken this definition are deemed to be on the AICS whether or not they
national and international standards.
?Please submit each E-Notification as one package (delivered by Post or courier) containing:
and the `Glossary of key exposure assessment terms' with a range of stakeholders in Australia and New Zealand. The draft are specifically listed.
?a CD or disk with self-assessment or draft (template) report file,
?Mutagenicity ?updating the IPCS Qualitative Scheme for Mutagenicity report was released for public comment in March 2005 and is available Significant international activity in relation to hair dyes is under way
?print-out(s) of all files on the disk or CD, and
(the degree or measure of the ability to cause mutation), and on the NICNAS website at http://www.nicnas.gov.au/obligations/ Natural and organic are not recognised by Australian regulators
in the European Union via its advisory committee, the Scientific Committee
?a hard copy print-out of all supporting data: spectra, physico-chemical tests, tox reports, MSDS, label etc
?Reproductive and developmental toxicity ?development of harmonised reform/default.asp. All comments received will be considered for inclusion because neither the Act nor the Trade Practices Act defines them.
on Consumer Products (SCCP). The committee is undertaking a full review
?Please send:
morphological terms. in the report. of all chemicals used in permanent hair dyes. The SCCP has requested
?DUPLICATE HARD COPIES for PLC, Non-PLC, LTD Cosmetic or therapeutic good?
industry to provide available data on mutagenicity and carcinogenicity
The Cincinnati steering group also proposed new work in four areas: The final report will be presented to regulators in Australia and New The difference between a cosmetic and a therapeutic product is determined
for all hair dye chemicals.
and STD certificate notifications
?Aggregate/cumulative risk assessment Zealand. Once the trans-Tasman regulatory position is determined mainly by product claims (a word, a sentence, a paragraph or implication
?ONE COPY ONLY for CEC and LVC permits.
?Data quality in exposure assessment in relation to the product categories under review, NICNAS will consider on a product label, package insert or advertisement). The TGA regulates
NICNAS maintains a watching brief on the activities of the SCCP. NICNAS
We request hard copies of all electronic files because our fees are based on the average cost of processing an assessment.
?Immunotoxicity (skin sensitisation) those products recommended for regulation as cosmetics. `products' that make therapeutic claims. The Cosmetics Claims Guidelines
is currently working cooperatively with the Australian cosmetics industry
If printing submissions becomes a significant additional cost, it will eventually be reflected in the fees we charge.
?Guidance for problem formulation in the risk assessment process. (see below) provide guidance on therapeutic and cosmetic product claims.
to develop a list of chemicals used in permanent hair dye preparations
The three latter areas will be addressed using a new `sharp-focus' approach in Australia with clarification on whether or not international restrictions
in order to produce shorter, targeted guidance. More information
are voluntarily complied with by the Australian cosmetics industry.
?For details of Australian cosmetics regulation see Your guide
This list will be made publicly available and updated as required.
Harmonisation's benefits to keeping cosmetics safe ?available at
?Improves health risk assessment http://www.nicnas.gov.au/australia/cosmetics.asp
For further information, please contact:
The Australian High Volume Industrial Chemicals List
?Establishes common principles, understanding and approaches Jun Zhang, Team Leader, Cosmetics
and enhanced transparency in risk assessment, facilitating ? For details of how the Australian Competition and Consumer
Phone: (02) 8577 8882
use for regulatory purposes Commission takes action on misleading or deceptive claims
Email: jun.zhang@nicnas.gov.au.
Since 1988, existing chemicals activities in the Organisation for Economic The first Australian High Volume Industrial Chemicals List (HVICL) was
?Promotes best practice science on cosmetic product labels see
Cooperation and Development (OECD) have primarily centred completed and published by NICNAS in July 2002. The list contains
?Enhances the availability of chemical safety information globally http://www.accc.gov.au/content/index.phtml/itemId/323594
on the investigation of high production volume (HPV) chemicals, based information about the volume of the chemicals manufactured or imported
thereby reducing costs
on the assumption that figures for production volume serve as a surrogate at high volumes in Australia, which industries introduce the chemicals
?Delivers safer chemical use and sustainable development ? The National Coordinating Committee on Therapeutic Goods' Cosmetic
for data on occupational, consumer and environmental exposure. and general uses of the chemicals. The list also serves as a useful source
?Promotes healthy populations Claims Guidelines provides guidance on acceptable and unacceptable
of information about chemicals for both NICNAS and the community. cosmetic claims, and is available at
HPV chemicals include all chemicals reported to be produced or imported
More details about the Harmonization Project ?including updates on new http://www.tga.health.gov.au/docs/html/cosclaim.htm
at levels greater than 1,000 tonnes per year in at least one OECD member The HVICL is to be updated every three to four years, with the next update
projects ?is available at:
country or in the European Union. The overall objectives of the HPV due to begin in 2005-06. The updated list will enable NICNAS to continue
http://www.who.int/ipcs/methods/harmonization/en/
Chemicals Program are to cooperatively undertake an initial assessment supporting the international assessment of chemicals of particular
of HPV chemicals, to screen them and agree on the need for further work. importance to Australian industry, the community and the environment.
The publication of the Australian HVICL also addresses the increasing
One of the main features of the Program is that member countries share the public demand for easily accessible information on chemicals.
burden of investigating HPV chemicals and benefit, in turn, from receiving
Four th NICNAS Innovation Award
data on other priority HPV chemicals from other member countries. For more information on the OECD High Production Volume (HPV) Program,
Industry benefits as the possible duplication of safety testing is eliminated. please visit: www.nicnas.gov.au/foreign/OECPHPVP.asp.
In June 1999, the OECD decided to base the future determination More information on the forthcoming HVICL project will be available from Hana's innovative approach resulted in the development of policies
We seek to continuously create a work environment that encourages
of individual country contributions to the Program on national production the NICNAS website over coming months. and procedures which are now integrated into NICNAS's work program,
creativity and new ways of improving our performance at NICNAS,
of high volume chemicals. Hence, as an OECD member, Australia shares strengthening its compliance presence internally and externally. Her
and along with Excellence, Cooperation and Achievement, Innovation
an obligation to contribute to the assessment of industrial chemicals Manufacturers and importers wishing to register now for receipt of guidance enthusiasm and commitment to her work increased staff knowledge through
is one of our key organisational values. INNO
V
carried out under the Program. material and a reporting package should contact: training and furthered NICNAS's relationship with stakeholders, significantly
AT
Cameron Dalgleish, Research Officer, Data Analysis & Information improving industry's compliance with the requirements of the Act.
Photo: Members of the Harmonization Steering Committee met at Cincinnati in October 2004. The NICNAS Innovation Award, introduced in 2001, recognises staff
IO
On a national level, it is important for the regulator to be aware of which Phone: (02) 8577 8817
NNER
who make a substantial contribution to the organisation.
chemicals are manufactured and/or imported into the country in high Email: cameron.dalgleish@nicnas.gov.au Hana worked with industry to develop training, resource materials and
WA
volumes. This enables NICNAS to identify potential high risk chemicals and procedures which meet NICNAS requirements yet do not place unnecessary
Hana Hamdan, leader of NICNAS's Notification and Assessment Team,
assists in better streamlining our existing chemical assessment activities.
R
regulatory burdens on those complying. The Award also recognised the fact
was the recipient of the NICNAS Innovation Award in 2004. D
* INN
that this `light touch' regulatory approach helps Australia meet
It specifically recognised Hana's work in her previous role as leader
its obligations under the Rotterdam Convention.
of NICNAS's Compliance Team, especially her outstanding contribution
to the development of a strengthened compliance program and improved Hana Hamdan
stakeholder engagement.
CHANGES TO NICNAS FEES AND CHARGES O
For further information, please contact NICNAS on:
From 1 July 2005 new fees and charges apply for new chemicals Other Applications
Phone: (02) 8577 8800 or 1800 638 528 (Free call)
assessments and Australian Inventory of Chemical Substances (AICS). 7,417 7,685
Secondary notification chemicals
Fax: (02) 8577 8888
NICNAS Registration fees and charges remain unchanged. other than PLC
Email: info@nicnas.gov.au
3,205 3,321
Secondary notification PLC
or visit our website at www.nicnas.gov.au
Approved Foreign Scheme ?Standard b
The increases for 2005-06 are modest: a 3.63% increase in new chemicals 7,417 7,685
Approved Foreign Scheme ?Limited b
assessment fees and charges that has been negotiated with and signed 5,974 6,191
Alternate State Law Applicationb
off by industry through the NICNAS Industry Government Consultative 8,012 8,302
Committee.
New Chemicals and AICS Charges
The following table outlines fees and charges for new chemicals New Chemical Assessment
assessments, AICS and NICNAS Registration. 1,058 1,097
Variation of Data Requirements
5,504 5,704
Nomination of Foreign Scheme
Schedule of current and revised fees and charges 589 609
Exempt Information
588 609
Application to Vary Assessment Report
Current Price $ a New Price $ a 588 609
Application to Vary Full Public Report
New Chemicals Fees AICS
Certificate Applications 1,176 1,219
Confidential Listing
Standard Assessment 1,588 1,645
Retain Confidential Listing
13,391 13,877
Limited Assessment 588 609
Early Non-confidential Listing
11,216 11,623
Polymer of Low Concern Assessment 1,577 1,634
Transfer to Confidential Listing
3,777 3,914
Extension of Assessment Certificate 529 548
Holder of a Confidence
2,404 2,491
Self-assessment Certificate Applications NICNAS Registration
Self-Assessment Polymer of Low Concern 353 Unchanged
Annual Registration fee (Tiers 1, 2 & 3)
2,266 2,348
Self-Assessment Non-hazardous polymer 1,058 Unchanged
Annual Registration charge Tier 2
6,730 6,974
(NAMW>1000) 7,879 Unchanged
Annual Registration charge Tier 3
Self-Assessment Non-hazardous chemical 8,035 8,326
Notes:
Permit Applications a) All NICNAS fees and charges are in Australian Dollars and are GST free.
Commercial Evaluation Permit 2,976 3,084 All amounts are rounded to nearest $.
Commercial Evaluation Permit Renewal 588 609 b) Whilst fees have been set for these applications, at present there are
Low Volume Chemical Permit 2,976 3,084 no Approved Foreign Schemes or Alternate State Laws in Australia.
Low Volume Chemical Permit Renewal 588 609
Early Introduction Permit 573 593
Section 30 Permit 6,490 6,725
New location for pportune Moment for
NICNAS's Formaldehyde
OCS Canberra Report scheduled for Public Trans-Tasman networking
Release On his way to speaking at the recent HazMat 2005 Conference, Peter
The Office of Chemical Safety (OCS) Canberra Office, which includes Human
Dawson, Principal Scientist, Hazardous Substances at New Zealand's
Health Risk Assessment, National Drugs and Poisons Schedule Committee
Formaldehyde (CAS No. 50-00-0) was declared a Priority Existing Chemical Environmental Risk Management Authority (ERMA ?Nga Kaiwhakat鹥ato
(NDPSC) Secretariat and Treaties and Compliance moved from Barton
(PEC) on 1 March 2002, for review. The chemical was nominated because Whakararu Taiao) visited staff at NICNAS. Under discussion was the
to Woden with effect from 22 March 2005.
of potential health concerns and to assess the adequacy of the current five-year workplan established under the Trans-Tasman Mutual Recognition
If you haven't already done so, please update your records with our new national workplace exposure standards for formaldehyde. Arrangement (TTMRA) Chemicals Cooperation Program. This Program
contact details
embodies our ongoing efforts to identify elements of chemicals regulation
Telephone: 02 6289 3200 NICNAS conducted risk assessments for workers, the general public that may be conducive to mutual recognition or harmonisation between
Facsimile: 02 6289 3299 and the environment. A draft assessment report was prepared. Australia and New Zealand.
Treaties and Compliance Facsimile: 02 6289 3260
Over the coming weeks NICNAS will meet with applicants (organisations
Street Address: Ground Floor, 10 Corinna Street, Woden ACT 2606
or individuals who applied for the assessment during the review) in Sydney
Postal Address: PO Box 100, Woden ACT 2606 and Melbourne to present the key findings of the assessment
and the proposed recommendations. At the meetings, NICNAS will outline
Website: www.tga.gov.au/chemicals/ocs/
the statutory consultation process and, at the same time, provide the draft
Contact details for the OCS Sydney Office (incorporating NICNAS) report to all applicants for their editorial comment/correction.
at Marrickville remain unchanged.
It is expected that the draft report will be released for public comment
in August or September 2005. All interested parties will then be encouraged
to provide further comments on the draft report.
For further information, please contact:
Jun Zhang, Team Leader, Cosmetics
Phone: (02) 8577 8882
Email: jun.zhang@nicnas.gov.au Peter Dawson (ERMA New Zealand ?second from right) and Bob Graf (NICNAS Reform
Team Leader ?third from left) in discussion with four members of the NICNAS Notification
and Assessment Team (left to right): Bill Diver, Rosemary Sager, Venky Krishnamurthy
and Naomi Degabriele.
OCS's new building at Woden ACT.
Polybrominated Flame Retardants ?an ongoing issue of concern
?the products of non-brominated technologies for non-flammability, and
Australian industry has acted on NICNAS's recommendation to move away The survey also confirmed that some companies import articles (such as
TVs, high definition set top boxes1, DVDs, video projectors, cookware, white ?decabromodiphenyl ether, in some cases.
from the use of the flame retardants pentabromodiphenyl ether (PeBDPE)
goods and polyethylene foam acoustic panels) containing PBFRs. Quantities
and octabromodiphenyl ether (OBDPE) which are known to have potential
of PBFRs imported in such articles are also included in Table 1. Given that
adverse health effects, to flame retardants known to be less hazardous.
Report findings in brief
not all companies importing articles containing PBFRs may have responded,
Furthermore, industry has indicated that they will completely phase out the
Sixteen companies responded to NICNAS's call for information about
the total quantity of PBFRs entering Australia in such articles is not known.
use of PeBDPE and OBDPE by the end of this year. These are some of the
PBFR use in 2003-04. Their reports indicated that no PBFRs were
findings of a recent NICNAS survey into the use of Polybrominated Flame
manufactured in Australia and that, compared to 1998-99, there was:
Table 1: Import Quantities of Polybrominated Flame Retardants
Retardants (PBFRs) conducted in October 2004.
?a 25% (146 tonnes) reduction in the quantity of PBFRs imported
QTY IN TONNES (from 576 tonnes in 1998-99 to 430 tonnes in 2003-04)
In view of the survey's findings and other research, NICNAS now plans
Chemical CAS* Number 2003/04 1998/99 ?around 70% decrease in import of PeBDPE
to review the three commonly used PBFRs in Australia: decabromodiphenyl
?around 90% decrease in import of OBDPE
ether (DBDPE), hexabromocyclododecane and tetrabromobisphenol A, Decabromodiphenyl ether 1163-19-5 180 177
?~1% increase in the use of DBDPE, the PBFR imported
to ascertain their risk to human health and the environment. Tetrabromobisphenol A 79-94-7 69 32
in the greatest quantity
25637-99-4 64 36
Hexabromocyclododecane
?an increase in the use of other PBFRs in place of polybrominated
The NICNAS findings were based on information provided by companies
QUANTITY BETWEEN 10 AND 30 TONNES IMPORTED IN 12 MONTHS TO OCTOBER 2004
diphenyl ethers:
that manufactured or imported one or more PBFRs (or mixtures or articles
26
Benzene, ethenyl-, homopolymer, brominated 88497-56-7 ?78% increase in the import of hexabromocyclododecane, and
containing PBFRs) and those that held relevant information about PBFRs
72
Pentabromodiphenyl ether 32534-81-9 ?116% increase in the import of tetrabromobisphenol A.
such as users, past importers and manufacturers. Companies were 10-30
TONNES
requested to report both on PBFRs and on their alternatives. Tetrabromobisphenol A bis
29
21850-44-2
(2,3-dibromopropyl) ether 21850-44-2 The companies also reported that sales of PeBDPE and OBDPE have
22
Tetrabromodiphenyl ether 40088-47-9 already ceased or will cease by the end of 2005.
PBFR use widespread
* Chemical Abstracts Service
While PBFRs reduce the flammability of textiles and serve to reduce
the risk of fire in dwellings, the survey confirmed their use in the Australian
Ten other commercially available PBFR chemicals including
manufacture of such items as:
octabromodiphenyl ether (OBDPE) were imported in quantities less than ten
?switchgear and armatures, wire insulation (including high voltage
tonnes during the 12 months prior to October 2004. The figures indicate
electrical cabling) and wiring in electrical and engineering appliances,
For more information, please contact
major decreases in the import of both PeBDPE and OBDPE compared to the
where polymers are used
Janith Wickramaratna, Review and Treaties
quantities of each imported in 1998-99. Detailed information concerning the
?moulded furniture, bedding, whitegoods, motor vehicles, packaging,
Phone: (02) 8577 8846
2003-04 findings is available in the May 2005 edition of Chemical Gazette
baby car seats and insulation, where polyurethane and polystyrene
Email: janith.wickramaratna@nicnas.gov.au
(see www.nicnas.gov.au/publications/gazette/chemgazettemay2005.asp).
foams are used
?hot melt adhesives for carpet backing and epoxy resin formulations
Virginia Parish, Review and Treaties
Flame retardant alternatives
for the aerospace market
Phone: (02) 85778893
Confirming the impact of NICNAS's previous warnings about the hazards
?canvas products, curtains, fabrics for motor vehicles, aircraft
Email: virginia.parish@nicnas.gov.au
of some PBFRs, the survey established that several other flame retardants
and public transport, and other textile and paper products, and
are being used as substitutes to PeBDPE and OBDPE. They include:
?computer printers.
?a newer and less hazardous brominated flame retardant
(i.e. Firemaster BZ-54)
Table 1 lists the commonly used PBFRs, imported in either the pure form
?chlorinated flame retardants (in polyurethane foam manufacture)
or as an ingredient of a chemical mixture. Where a PBFR was reported as 1 The importer of high definition set top boxes indicated that the use of PBFRs in these products
?alumina dihydrate (used in latex formulations by one
an ingredient in a mixture, only the quantity of the PBFR has been included. is being phased out.
carpet manufacturer)
... Stop press ... Stop press ... Stop press ... Stop press ... Stop press ...
Flame Retardants as Priority Existing Chemicals
is received during the twelve months that the chemicals have been listed ?Decabromodiphenyl ether ?DBDPE (also known as decabromodiphenyl
Octabromobiphenyl and Decabromobiphenyl
as PECs and the Director has not called for them to be assessed (under oxide) ?(CAS No. 1163-19-5) and
Octabromobiphenyl (CAS No. 27858-07-7) and decabromobiphenyl (CAS No.
subsection 57[2] of the Act), the Director must remove the particulars of the ?Hexabromocyclododecane ?HBCD ?(CAS No. 25637-99-4 and
13654-09-6) were declared Priority Existing Chemicals (PECs) for full
chemicals from the Australian Inventory of Chemical Substances (AICS). 3194-55-6) and
assessment on 6 July 2004.
?Tetrabromobisphenol A ?TBBPA ?(CAS No. 79-94-7)
This would mean that future import or manufacture of the chemicals will
In accordance with the Industrial Chemicals (Notification and Assessment)
require notification and assessment as new chemicals. as Priority Existing Chemicals (PECs) for full risk assessment
Act 1989 (the Act) all those who wish to manufacture or import
octabromobiphenyl or decabromobiphenyl during the period that these
Decabromodiphenyl ether, Hexabromocyclododecane and Full details and explanations of these declarations are available in the June
chemicals are PECs must apply in writing using the PEC application form.
Tetrabromobisphenol A 2005 Chemical Gazette at
In accordance with section 51 of the Act, the Minister for Health and Ageing http://www.nicnas.gov.au/publications/gazette/chemgazettejun2005.asp
To date, the NICNAS Director has not received any application for the
has declared:
assessment of these chemicals, and (under section 63 of the Act) if none
Sodium Cyanide PEC Review update
Sodium cyanide was declared a Priority Existing Chemical (PEC) for full access information concerning current controls for sodium cyanide and make Gold Council and the Minerals Council of Australia facilitating the collection
environmental risk assessment in May 2002, with the assessment recommendations for minimising risks, as appropriate. of this data.
to be conducted by the Department of the Environment and Heritage (DEH)
for NICNAS. As part of the assessment process NICNAS held public consultation This second data-gathering phase was completed in February 2005, and the
meetings in March 2004 in a number of major cities to present data gaps additional data submitted is now being reviewed. This data will be used to
The main use of sodium cyanide is in gold mining, and it was declared and identify any data not provided to NICNAS during the assessment. update the environmental exposure section of the PEC report. Furthermore,
a PEC as its widespread use provides a number of ways for it to enter into it will allow conservative `default' values to be replaced, where appropriate,
the environment. Cyanides have high acute toxicity to aquatic life, birds Significant data not seen by NICNAS were identified. Therefore a second with measured data, thus leading to a more robust risk assessment.
and mammals, and avian poisonings have been reported in Australia data-gathering exercise was undertaken to obtain this data, for assessment.
as a result of the consumption of cyanide-contaminated environmental Sections of the draft PEC report will then be sent to external peer reviewers,
media at tailings dams. As part of this data collation, the State and Territory Agencies regulating where appropriate. A draft assessment report is likely to be completed by
mines were approached for data relating to environmental risk issues the end of July 2005, with stakeholder engagement running in August 2005.
The PEC review will determine the potential for environmental exposure and risk management aspects of sodium cyanide. Data on groundwater
in Australia and the hazards of sodium cyanide so that the risk of adverse and tailings dam monitoring, contamination issues, wildlife protocols and
effects to the environment can be determined. Furthermore the review will incidents involving cyanide were obtained from industry, with the Australian
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